510(k) K250788

Definium Tempo Select by Ge Hualun Medical Systems Co. , Ltd. — Product Code KPR

K250788 is an FDA 510(k) premarket notification submitted by Ge Hualun Medical Systems Co. , Ltd. for the device "Definium Tempo Select". The FDA issued a decision of Substantially Equivalent on August 28, 2025. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Ge Hualun Medical Systems Co. , Ltd. has at least 10 other 510(k) clearances on record.